At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,824 enrolled
Drug / intervention
Liberal Cell Transfusion +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
In Brief
A clinical study evaluating Liberal Cell Transfusion and Restricted red cell transfusion for Infant, Newborn, Diseases and 4 related conditions. Completed, enrolled 1,824 participants across 20 sites.
Detailed Summary
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD), Anemia
CountriesUnited States
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartDec 2012
Primary CompletionJan 2020
Study CompletionApr 2025
TodayJul 2026
First PostedOct 8, 2012
Enrollment StartDec 1, 2012
Primary CompletionJan 1, 2020
Study CompletionApr 29, 2025
TodayJul 1, 2026
Enrollment to primary: 7.1 yearsPosted 13.7 years ago
Interventions
Liberal Cell Transfusionprocedure
Restricted red cell transfusionprocedure